Catheter tunneling systems, instruments and methods

ABSTRACT

An instrument for facilitating insertion of a catheter through a subcutaneous tunnel includes a tunneling stylet defining a longitudinal axis and having leading and trailing ends, a bifurcated segment adjacent the leading end of the tunneling stylet and a releasable cover releasably mountable to the leading end of the tunneling stylet to substantially enclose the bifurcated segment. The bifurcated segment includes first and second elements adapted for reception within respective lumens of a catheter.

CROSS REFERENCE TO RELATED APPLICATION(S)

This application claims priority to, and the benefit of, U.S.Provisional Application Ser. No. 60/904,462, filed Mar. 2, 2007.

BACKGROUND

1. Technical Field

The present disclosure relates generally to catheter tunneling systems,instruments and methods and, more particularly, relates to a cathetertunneling instrument utilized in connection with a hemodialysisprocedure.

2. Description of the Related Art

Catheters are flexible medical instruments intended for the withdrawaland introduction of fluids relative to body cavities, ducts, andvessels. Catheter instrumentation may have particular application in ahemodialysis procedure where blood is withdrawn from a blood vessel fortreatment, and subsequently returned to the blood vessel forcirculation. Known hemodialysis catheters include multiple lumens, suchas dual lumen or triple-lumen catheters, permitting bi-directional fluidflow within the catheter whereby one lumen is dedicated for withdrawalof blood and the other lumen is dedicated for returning the treatedblood to the vessel. During an exemplary hemodialysis procedure, amultiple lumen catheter is inserted into a body and blood is withdrawnthrough an arterial lumen of the catheter. The removed blood is directedto a hemodialysis unit which dialyzes, or purifies, the blood to removewaste, and toxins. The dialyzed blood is returned to the patient througha venous lumen of the catheter.

Various techniques are employed for the insertion of hemodialysiscatheters including, e.g., with the use of guidewires, introductionstylets or the like. Some of these known techniques include subcutaneoustunneling methodologies where a subcutaneous tunnel is formed betweentwo spaced openings in the skin with the use of a trocar or the like.The catheter end is attached to the trocar and pulled though the tunnelto expose the catheter which is subsequently inserted into, e.g., thejugular vein and routed to the heart.

SUMMARY

Accordingly, the present disclosure is directed to an instrument forfacilitating insertion of a catheter through a subcutaneous tunnel. Theinstrument includes a tunneling stylet defining a longitudinal axis andhaving leading and trailing ends, a bifurcated segment adjacent theleading end of the tunneling stylet and having first and second elementsadapted for reception within respective lumens of a catheter and areleasable cover releasably mountable to the leading end of thetunneling stylet to at least partially enclose the bifurcated segment.The instrument may further include a dilation member releasablymountable to the leading end of the tunneling stylet in the absence ofthe releasable cover. The dilation member is dimensioned to generallyincrease an internal dimension of the subcutaneous tunnel. Thebifurcated segment may be releasably mountable to the tunneling stylet.

The first and second elements of the bifurcated segment each may includean outer peripheral rib dimensioned to facilitate gripping engagementwith an internal surface of a respective lumen of the catheter. Thefirst and second elements of the bifurcated segment may include aplurality of spaced outer peripheral ribs. At least one of theperipheral ribs has a tapered profile for facilitating insertion of thefirst and second elements within respective lumens of the catheter. Thefirst element of the bifurcated segment may have a first longitudinallength and the second element of the bifurcated segment may have asecond longitudinal length with the first length being greater than thesecond length to facilitate insertion within the catheter.

The leading end of the tunneling stylet may define a collar locatedproximally relative to the bifurcated segment. The leading end also mayinclude an external thread adjacent the collar for facilitating secureengagement to the releasable cover. The leading end may be arranged atan oblique angle with respect to the longitudinal axis of the tunnelingstylet.

The instrument may include a handle positioned adjacent the trailing endof the tunneling stylet and adapted to facilitate engagement by aclinician. The handle may include an offset segment and a grippingsegment. The offset segment may be arranged at an oblique angle withrespect to the longitudinal axis of the tunneling stylet to displace thegripping segment from the longitudinal axis.

In another embodiment, an instrument for facilitating insertion of acatheter through a subcutaneous tunnel includes a tunneling styletdefining a longitudinal axis and having leading and trailing ends and abifurcated segment adjacent the leading end of the tunneling stylet. Thebifurcated segment includes first and second elements adapted forreception within respective lumens of a catheter. The first element andthe second element define respective first and second longitudinallengths. The first longitudinal length is greater than the secondlongitudinal length to assist in positioning within the catheter. Thebifurcated segment may be securely connected to the tunneling stylet orreleasably connected to the tunneling stylet.

In another embodiment, an instrument for facilitating insertion of acatheter through a subcutaneous tunnel includes a tunneling stylethaving first and second segments, a bifurcated segment releasablyconnectable to the first segment and a dilation member releasablyconnectable to the first segment in the absence of the bifurcatedsegment. The first segment of the tunneling stylet defines alongitudinal axis along at least a portion of a length thereof and thesecond segment is dimensioned for passage through tissue. The bifurcatedsegment includes first and second mounting elements adapted forreception within respective lumens of the catheter. The dilation memberis dimensioned to generally increase an internal dimension of thesubcutaneous tunnel. The first segment of the tunneling stylet and thebifurcated segment may include cooperative threaded portions forestablishing a releasable connection therebetween. The first segment ofthe tunneling stylet and the dilation member may include cooperativethreaded portions for establishing a releasable connection therebetween.

A method for implanting a catheter for use in a hemodialysis procedureis also disclosed. The method includes the steps of:

providing a tunneling instrument including a tunneling stylet havingleading and trailing ends, a catheter connector segment adjacent thetrailing end and a releasable cover adjacent the leading end and atleast partially mounted about the connector segment;

accessing the venous system of a subject with one end of a hemodialysiscatheter;

advancing the leading end of the tunneling stylet with mountedreleasable cover subcutaneously through the tissue in a first directionto at least partially expose the releasable cover through a first tissueopening;

removing the releasable cover from the catheter connector segment;

fluidly connecting the catheter connector segment to a second catheterend of the hemodialysis catheter;

retracting the tunneling stylet and the second catheter end in a seconddirection opposite of the first direction to expose the second catheterend through a second tissue opening; and

connecting the second catheter end to a hemodialysis apparatus.

In the alternative, a method for implanting a catheter for use in ahemodialysis procedure, includes the steps of:

providing a tunneling instrument including a tunneling stylet havingleading and trailing ends and a catheter connector segment releasablyconnected to the trailing end;

accessing the venous system through a first tissue opening of a subjectwith a first end of a hemodialysis catheter;

mounting the catheter connector segment to a second end to substantiallyseal a lumen within the catheter;

releasably connecting the tunneling stylet to the catheter connectorsegment;

advancing the leading end of the tunneling stylet subcutaneously throughthe tissue to expose the second catheter end through a second tissueopening; and

connecting the second catheter end to a hemodialysis apparatus.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiments of the disclosure will be better understood withreference to the accompanying drawings wherein:

FIG. 1 is a perspective of a tunneling instrument in accordance with theprinciples of the present disclosure illustrating the tunneling stylet,the bifurcated segment and the releasable cover;

FIG. 1A is an enlarged perspective view of the area of detail indicatedin FIG. 1 illustrating the bifurcated segment and the releasable cover;

FIG. 2 is a perspective view of the tunneling instrument of FIG. 1 withthe releasable cover mounted to the tunneling stylet;

FIG. 2A is an enlarged perspective view of the area of detail indicatedin FIG. 2;

FIG. 3 is a perspective view of the tunneling instrument of FIG. 1 andan optional dilation member releasably mountable to the tunnelingstylet;

FIG. 3A is an enlarged perspective view of the area of detail indicatedin FIG. 3;

FIG. 4 is a perspective view of the tunneling instrument illustratingthe dilation member mounted to the tunneling stylet;

FIG. 4A is an enlarged perspective view of the area of detail indicatedin FIG. 4;

FIG. 5 is a view of the chest area of a patient illustrating amethodology use of the tunneling instrument through a reverse tunnelingprocedure;

FIG. 6 is an enlarged perspective view illustrating the tunneling styletin position for mounting to the catheter;

FIG. 7 is a view similar to the view of FIG. 5 further illustrating themethodology of use of the tunneling instrument;

FIG. 8 is a side plan view of an alternate embodiment of the tunnelinginstrument illustrating the tunneling stylet, the releasable bifurcatedsegment and the releasable dilation member;

FIG. 9 is a view of the chest area of a subject illustrating a methodfor creating a subcutaneous tunnel for implanting a hemodialysiscatheter with the tunneling instrument of FIG. 8;

FIG. 10 is a perspective view illustrating mounting of the releasablebifurcated segment to the catheter;

FIG. 11 is a perspective view illustrating mounting of the releasablebifurcated segment to the tunneling stylet;

FIG. 12 is a view similar to the view of FIG. 9 illustrating thetunneling stylet advanced through an exit opening to expose the catheterend;

FIG. 13 is a perspective view of an alternate embodiment of theinstrument of FIG. 8;

FIG. 14 is a perspective view of an alternate embodiment of theinstrument of FIG. 1;

FIG. 14A is a perspective view of a further embodiment of the instrumentof FIG. 1; and

FIG. 15 is an enlarged view of the leading end of the tunneling styletand mounted cover of the instrument of FIG. 14.

DETAILED DESCRIPTION OF THE EMBODIMENTS

The exemplary embodiments of the tunneling instruments, systems andassociated methods of use have several applications. For instance, aclinician may utilize the disclosed tunneling instrument to facilitatethe insertion of a catheter in a subcutaneous tunnel during ahemodialysis procedure. It is envisioned, however, that the presentdisclosure may be employed in a wide range of applications includingsurgical, diagnostic and related treatments of diseases and bodyailments of a subject.

In the discussion that follows, the term “proximal” or “trailing” refersto the portion of a structure that is closer to a clinician, while theterm “distal” or “leading” refers to the portion that is farther fromthe clinician. As used herein, the term “subject” refers to a humanpatient or other animal. The term “clinician” refers to a doctor, nurseor other care provider and may include support personnel.

The following discussion includes a description of the tunneling systemsfollowed by a description of exemplary associated methods of using thetunneling systems in insertion of a hemodialysis catheter. The methodscontemplated include a variety of tunneling procedures, including, but,not limited to reverse tunneling procedures and ante-grade tunnelingprocedures. However, those skilled in the art will appreciate thecatheter has many other applications in addition to dialysisapplications.

Referring now to the drawings wherein like components are designated bylike reference numerals throughout the several views, FIGS. 1-1Aillustrate the tunneling instrument in accordance with the principles ofthe present disclosure. Tunneling instrument 100 includes tunneling orinsertion stylet 102 and releasable cover 104, which is releasablymountable to the tunneling stylet 102. Releasable cover 104 will bediscussed in greater detail hereinbelow. Tunneling stylet 102 defineslongitudinal axis “k” and has trailing and leading ends 106, 108,respectively. Tunneling stylet 102 is fabricated from a biocompatiblemetal such as stainless steel or titanium or a suitable polymericmaterial. Tunneling stylet 102 may be adapted to bend to facilitateadvancement through the subcutaneous tissue. For example, tunnelingstylet 102 may be bent or altered in configuration to assist inmanipulation through the subcutaneous tissue. Tunneling stylet 102 mayincorporate various indicia or gradation markings 110 along its lengthto assist to clinician in determining the depth of insertion of thetunneling stylet 102. Gradation markings 110 may also consist of variousradiopaque markings that are detectable during an x-ray scanningprocedure.

Trailing end 106 may include handle 112 which is dimensioned formanipulation by the clinician. Handle 112 may incorporate anyarrangement suitable to enhance gripping engagement by the clinician. Inone embodiment, handle 112 includes a loop. The configuration of theloop of handle 112 enables the clinician to position his fingers withinthe loop when pulling tunneling stylet 102 through a subcutaneoustunnel. Handle 112 may incorporate an ergonomic arrangement or any otherarrangement suitable for grasping engagement by a clinician.

With continued reference to FIGS. 1-1A, tunneling stylet 102 includescatheter mounting or bifurcated segment 114 adjacent leading end 108.Bifurcated segment 114 incorporates first and second mounting elements116,118 which are radially spaced to define gap 120 therebetween. Firstand second mounting elements 116,118 are dimensioned to be receivedwithin respective lumens of a catheter as will be discussed hereinbelow.First mounting element 116 defines a length which is greater than acorresponding length of a second mounting element 118. This staggeredlength arrangement may facilitate insertion of first and second mountingelements 116, 118 within the lumens of the catheter. First and secondmounting elements 116, 118 each may include one or more locking ribs 122on their outer surfaces. Locking ribs 122 are dimensioned to facilitateengagement (e.g., frictional) with internal surfaces defining the lumensof the catheter. Locking ribs 122 of respective first and secondmounting elements 116, 118 may be longitudinally spaced from each otheras shown in FIG. 1A. In one arrangement, locking ribs 122 are tapered soas to gradually increase the effective cross-sectional dimensions ofrespective first and second mounting elements 116, 118 towards trailingend 106 of tunneling stylet 102 to facilitate insertion of the first andsecond mounting elements 116, 118 within the lumens of the catheter.

Leading end 106 further defines collar 124 proximal of bifurcatedsegment 114 and mounting means in the form of external thread 126between the collar 124 and the bifurcated segment 114.

Tunneling stylet 102, including trailing and leading ends 106,108 andbifurcated segment 114, may be integrally formed as a single unit.Alternatively, tunneling stylet 102 may be constructed of separablecomponents connectable to each other via various connection meansappreciated by one skilled the art.

Referring now to FIGS. 1-2, cover 104 will be discussed. Cover 104includes trailing section 128 and leading section 130. Trailing section128 is adapted to be positioned over bifurcated segment 114 tosubstantially enclose the bifurcated segment 114. Trailing section 128may be generally cylindrical in configuration. In one embodiment,trailing section 128 includes a single lumen 132 for reception of bothfirst and second mounting elements 116, 118 of bifurcated segment 114.In the alternative, trailing section 128 may include two distinct lumens(not shown) for receiving first and second mounting elements 116, 118respectively. Trailing section 128 may incorporate an internal thread129 as shown in the partial removed portions of cover 104 depicted inFIG. 1A. Internal thread 129 cooperates with external thread 126 oftunneling stylet 102 to releasably secure cover 104 to insertion stylet102. However, the internal thread is not needed to achieve theobjectives of the present disclosure. Leading section 130 of cover 104is generally tapered or frusto-conical in configuration to facilitatepassage of cover 104 and insertion stylet 102 through the subcutaneoustissue.

Cover 104 may be fabricated from a biocompatible metal or polymericmaterial as discussed hereinabove in connection with tunneling stylet102. Cover 104 may also be fabricated from a suitable elastomericmaterial capable of resiliently stretching when positioned overbifurcated segment 114.

FIGS. 2-2A illustrate cover 104 mounted to tunneling stylet 102. Asshown, trailing section 128 of cover 104 may engage collar 124 oftunneling stylet 102 to ensure that no tissue or fluids may enterbeneath the cover 104 and contact bifurcated segment 114. Trailingsection 128 may abut collar 124 or be at least partially positioned overthe collar 124. In the mounted condition of cover 104, locking ribs 122may engage the internal surface of the cover 104 to facilitatereleasable securement of the cover 104 relative to insertion stylet 102.Internal thread 129 (if provided) of cover 104 may threadably engageexternal thread 126 of tunneling stylet 102. Alternatively, if internalthread 129 is not incorporated into cover 104, external thread 126 mayengage internal surfaces within trailing section 128 of cover 104.External thread 126 may be replaced with a knurling, roughened surfaces,irregularities or the like to engage the internal surfaces of trailingsection 128.

Referring now to FIGS. 3-3A, tunneling instrument 100 may furtherinclude dilator element 134. Dilator element 134 is adapted forreleasable mounting to tunneling stylet 102. Dilator element 134 may beincorporated to dilate a portion of the subcutaneous tunnel to, e.g.,create an internal shelf within the subcutaneous tunnel to therebyfacilitate placement of a cuff connected to the external surface of thecatheter. Dilator element 134 includes trailing segment 136incorporating tapered segment 138 and cylindrical segment or collar 140.Dilator element 134 further includes intermediate segment 142 havingtapered segment 144, cylindrical segment 146 and tapered segment 148.Dilator element 134 further includes leading segment 150 which isgenerally cylindrical in configuration. Trailing segment 136 may definean outer diameter or dimension which is greater than a correspondingouter diameter or dimension of collar 124 of tunneling stylet 102. Thesignificance of this dimensioning will be discussed in greater detailhereinbelow.

Dilator element 134 may incorporate internal threads 152 which cooperatewith external threads 126 of tunneling stylet 102 to securely releasablyconnect the dilator element 134 to the tunneling stylet 102. Other meansfor releasably connecting dilator element 134 to tunneling stylet 102are also envisioned including bayonet coupling, snap lock, a frictionalrelationship lock of the like, or any other suitable connectingapparatus.

FIGS. 4-4A illustrate dilator element 134 mounted to tunneling stylet102. As shown, tapered segment 138 gradually tapers from cylindricalsegment 140 to define an outer diameter or dimension which generallyapproximates the outer diameter or dimension of collar 124 of tunnelingstylet 102. Thus, by virtue of this arrangement, tapered segment 138 maygradually increase the internal dimension of the subcutaneous tunnel toat least the maximum outer dimension of the tapered segment 138(corresponding to the dimension of cylindrical segment 140) whileinsertion stylet 102 is pulled through the subcutaneous tunnel.

The use of tunneling instrument 100 will now be discussed in terms of areverse tunneling procedure in connection with hemodialysis treatment.The application will be discussed in terms of deploying a catheterthrough the right jugular vein for positioning within the right atriumand creating a tunnel. In one application, catheter may be a dual lumencatheter including two generally D-shaped lumens separated by septumwall. For example, suitable catheters include the Mahurkar® dual andtriple lumen catheters available from Covidien. Other catheters are alsoenvisioned including triple lumen catheters, coaxial lumen catheters orany other suitable catheter having application in the removal and returnof fluids to and from the subject in, e.g., a hemodialysis procedure.The catheter may be fabricated from a suitable elastomeric,thermoplastic or polymeric material, and manufacturing through knownextrusion or molding techniques or any other conventionally acceptablemethodology. The catheter 200 is relatively flexible and may be capableof some deformation.

As appreciated, the catheter may be implanted in the right atrium viathe left jugular vein, the right atrium through the right subclavianvein, the right atrium through the left subclavian vein, or implanted inthe femoral vein of the subject.

Referring now to FIG. 5, the internal jugular vein 502 is located andpunctured with an introducer needle and a guidewire is inserted into thejugular vein 502 using known techniques. The needle is removed and theopening 500 from the skin to the jugular vein 502 is enlarged adjacentto and along the pathway of the guidewire into the jugular vein 502 sothat a catheter may be inserted in to the jugular vein 502. The leadingend of a catheter 200 is then inserted in to the opening 500, throughthe jugular vein 502, the superior vena cava 504, and into the rightatrium 506. The positioning of the leading end 204 of catheter 200 maybe confirmed with an x-ray if desired. The trailing end 202 of thecatheter may extend from the venotomy site 500.

Once the leading or distal end 204 of catheter 200 is in position,attention is directed to preparing the subcutaneous tunnel. A small exitsite or opening 508 is made adjacent the chest wall below the venotomysite 500 to define the base of the subcutaneous tunnel. Thereafter,tunneling stylet 102 with releasable cover 104 mounted thereto in thecondition depicted in FIGS. 2-2A is introduced into the subject throughthe exit site 508 and advanced toward the venotomy site 500 (in thedirection of arrow “B”) to create a subcutaneous tunnel. Releasablecover 104 of tunneling instrument 100 is designed with optimizedgeometry to permit effective dissection of subcutaneous tissue as it isadvanced toward the venotomy site 500. Once releasable cover 104 isexposed or extends from the venotomy site 500, the releasable cover 104is removed from tunneling stylet 102. Thereafter, optionally, dilatorelement 134 may be releasably secured to tunneling stylet 102 via any ofthe aforementioned connection means (e.g., through threaded cooperationof external threads 126 of tunneling stylet 102 and internal threads 152of dilator element 134), and the tunneling stylet 102 is retracted orpulled back a predetermined distance within the created subcutaneoustunnel. This activity consequently causes a portion of the subcutaneoustunnel adjacent the venotomy site 500 to be dilated due to taperedsegment 138 of dilator element 134 engaging the internal tissue. Thepredetermined distance will generally correspond to the desired locationof the cuff attached to the catheter 200. The juncture of the internaltissue dilated by dilator element 134 and the remaining portion of thesubcutaneous tunnel defines a ledge or shelf to accommodate the cuff ofthe catheter. Once the shelf is created, tunneling stylet 102 is againadvanced towards the venotomy site 500 to at least partially exposedilator element 134. Dilator element 134 is thereafter removed fromtunneling stylet 102.

Referring now to FIG. 6, catheter 200 is then secured to tunnelingstylet 102 by positioning first and second mounting elements 116,118 ofbifurcated segment 114 within respective lumens 206 of the catheter 200.Axial spacing of mounting elements 116, 118 (e.g., the difference in therespective lengths) facilitate insertion within the respective lumens206 of the catheter 200. Gap 120 between first and second mountingelements 116, 118 receive septum wall 208 of catheter 200. In oneembodiment, gap 120 is dimensioned whereby first and second mountingelements 116, 118 frictionally engage septum wall 208. Locking ribs 122on the external surfaces of first and second mounting elements 116,118frictionally engage the internals surfaces defining the lumens 206 ofthe catheter 200 in a manner to securely connect the catheter 200 tobifurcated segment 114. Cather portions adjacent lumens 206 may at leastpartially deform to receive first and second mounting elements 116, 118.

With the catheter 200 attached, tunneling stylet 102 is drawn or pulledback toward the exit site 508 in the direction of directional arrows “j”as shown in FIG. 7. Once the trailing end of the catheter 206 is exposedfrom the exit site 508, the catheter 200 is released from tunnelingstylet 102. The catheter 200 may then be fluidly connected to ahemodialysis machine. The clinician may employ a hub or any othersuitable device to establish fluid communication between the catheter200 and a hemodialysis machine. In FIG. 7, cuff 210 of catheter 200 isshown within the shelf “t” of the subcutaneous tunnel.

As a further alternate, it is envisioned that bifurcated segment 114 maybe releasably connectable to tunneling stylet 102. A tip (not shown) maybe connectable to tunneling stylet 102 during initial advancement oftunneling instrument 100 from the exit opening 508 to the venotomy site500. Dilator element 124 may be then optionally secured to tunnelingstylet 102 after the tip is removed to form the internal tissue ledge.Once the ledge is created, tunneling instrument 100 is advanced throughthe venotomy site 500 to remove dilator element 124 and attach thereleasable bifurcated segment 114 and catheter 200 to the tunnelinginstrument 100. Tunneling stylet 102 may be retracted through exit site508 in a similar manner to that described hereinabove.

FIG. 8 illustrates an alternative embodiment of the present disclosure.Tunneling instrument 1000 includes tunneling stylet 1002, bifurcatedsegment 1004 and dilator element 1006. Tunneling stylet 1002 includesfirst segment 1008 defining longitudinal axis “m” and second segment1010 extending from the first segment 1008 and obliquely arranged withrespect to the longitudinal axis “m.” Second or offset segment 1010 isdimensioned to facilitate passage through the subcutaneous tissue.Offset segment 1010 may incorporate any angular or arcuate arrangementsuitable to facilitate insertion and/or passage through the tissue whenthe insertion stylet 102 is manipulated by the clinician. Offset segment1010 defines a tapered configuration or a reduced cross-section areatoward its tip as shown. First segment 1008 of tunneling stylet 1002incorporates a threaded portion 1012 at its remote end. Bifurcatedsegment 1004 is substantially similar to the bifurcated segment 114 ofthe embodiment of FIG. 1; however, bifurcated segment 1004 is releasablymountable to tunneling stylet 1002. In one embodiment, bifurcatedsegment 1004 incorporates internal threads 1005 which mate with externalthreaded portion 1012 of tunneling stylet 1002 to releasably connect thebifurcated segment 1004 to the tunneling stylet 1002. Bifurcated segment1004 may be devoid of external threads adjacent first and secondmounting segments 116, 118. In all other respects, bifurcated segment1004 is substantially similar to the bifurcated segment 114 of theembodiment of FIG. 1.

Dilator element 1006 is substantially similar to the dilator element 134of the embodiment of FIG. 1, and reference is made to the foregoingdescription. As noted, dilator element 1006 includes an internal thread1014 which also is releasably mateable to external threaded portion 1012of tunneling stylet 1002 to releasably secure the dilator element 1006to the tunneling stylet 1002.

The use of tunneling instrument 1000 will now be described in connectionwith a reverse tunneling procedure incorporating the approach from thevenotomy site 500 to the exit opening 508. With reference to FIG. 9, inuse, a venotomy site 500 is made and the catheter 200 is placed withinthe right atrium through the venotomy site 500 in the manner discussedhereinabove. A guide wire may be positioned to access the heart tofacilitate insertion of the leading end 204 of catheter 200 within theheart through techniques known in the art. In accordance with oneembodiment, after catheter 200 is positioned within the right atrium orother desired site as discussed hereinabove, bifurcated segment 1004 ispositioned or mounted to the free or proximal end of the catheter 200extending outwardly from the venotomy site 500. Specifically, first andsecond mounting segments 116, 118 are advanced to be inserted withinlumens 206 of catheter 200 as shown in FIG. 10. This may seal the freeend of the catheter 200 to prevent or minimize leakage of blood andaspiration of air through catheter 200 prior to tunneling. FIG. 11illustrates bifurcated segment 1004 secured relative to catheter 200. Asdepicted, collar 1004 c of bifurcated segment 1004 is flush against theend face of catheter 200 to substantially seal the catheter end. Firstand second mounting segments 116, 118 also may define a cross-sectionaldimension approximating the internal dimensioning of lumens 206 toimpede flow of fluids past collar 1004 c and from the catheter end.

The procedure is continued by creating an exit site or opening 508beneath the venotomy site 500 adjacent the sternum. Thereafter, dilatorelement 1006 is optionally mounted to tunneling stylet 1002. Secondsegment 1010 of tunneling stylet 1002 optionally is then introducedinside the subject through the venotomy site 500 and advanced toward theexit opening 508. As tunneling stylet 1002 is advanced through the exitopening 508, dilator element 1006 engages internal tissue beneath thevenotomy site 500. An enlarged tissue tract is thereby made to create ashelf for accommodating the cuff 210 of the catheter 200 by advancingdilator element 1006 a predetermined distance through the venotomy site500 toward the exit opening 508. The predetermined distance correspondsto the desired location of the cuff 210. Tunneling stylet 1002 is thenretracted toward the venotomy site 500 and the dilator element 1006 isremoved from the tunneling stylet 1002. In an alternate method, e.g.,when another dilator instrument is used to create the subcutaneous shelfor when no shelf is necessary, tunneling stylet 1002 may be connecteddirectly to bifurcated segment either before or after mounting of thebifurcated segment 1004 to catheter 200.

Referring now to FIG. 11, bifurcated segment 1004 is then mounted toinsertion stylet 1002 through threaded cooperation of the threadedcomponents. Once the catheter 200 is secured, tunneling instrument 1000is readvanced from the venotomy site 500 through the exit opening 508until the bifurcated segment 1004 is exposed from the exit opening 508to expose the end of the catheter 200 as depicted in FIG. 12. Thecatheter 200 is removed from its mounting to tunneling instrument 1000and fluidly connected to a hemodialysis machine via a hub or multi-tubeconnector assembly. In one embodiment, catheter 200 is released from itsmounting to bifurcated segment 1004 by exerting a linear force oncatheter 200. Alternatively, the catheter 200 is severed or cut adjacentthe bifurcated segment 1004 to expose the catheter ends.

In an alternate embodiment depicted in FIG. 13, bifurcated segment 1004may be permanently attached to tunneling stylet 1002 as described inconnection with the embodiment of FIG. 1. In this embodiment, anotherdilator element may be used if desired to create the subcutaneous shelf.

FIGS. 14-15 illustrate an alternate tunneling instrument in accordancewith the present disclosure. Tunneling instrument 2000 is similar to theembodiment of FIG. 1. Tunneling instrument includes tunneling stylet2100, catheter connector segment 2200 and cover 2300. Connector orbifurcated segment 2200 may be similar to any of the aforedescribedbifurcated segments and may or may not be releasably mounted totunneling stylet 2100. Tunneling stylet 2100 includes stylet body 2102and handle 2104 disposed at one end of the stylet body 2102. Handle 2104maybe fabricated from a suitable polymeric material formed by injectionmolding techniques. Handle 2104 may be secured to stylet body 2102 withadhesives or the like or may be molded onto the stylet body 2102 duringmanufacture. Handle 2104 includes oblique segment 2106 adjacent styletbody 2102 which is arranged at an oblique angle “k” with respect to thelongitudinal axis “y” of stylet body 2102, and grasping segment 2108extending from the oblique segment 2106. Angle “k” may range from about30 degrees to about 60 degrees. Oblique segment 2106 displaces graspingsegment 2108 relative to the longitudinal axis “y”. This will displacethe clinician's hand from the chest area of the subject when, e.g., theclinician grasp's, with his/her palm, the grasping segment 2108. Thus,the clinician's hand is not encumbered by the chest area of the subjectand/or any other instrumentation extending from the chest. Obliquesegment 2106 also defines recess 2110 within which the clinician mayplace an index finger during manipulation of tunneling instrument 2000.Oblique segment 2106 may assume other configurations including a generalU-shape, sinusoidal shape, arcuate shape, polygonal shape or otherarrangements as appreciated by one skilled in the art.

In the alternative, a proximal portion 2102 p of the stylet body 2102may have a curved shaped, as shown in FIG. 14A thus displacing handle2108 both in the “x” and “z” directions as shown in FIG. 14A. Thismulti-plane offset arrangement may assist the clinician in steering thetunneling stylet 2100 through the subcutaneous tissue.

Tunneling stylet 2100 further defines an offset or oblique leading end2112 which is obliquely oriented relative to the longitudinal axis oftunneling stylet at an angle “n”. Angle “n” ranges from about 5 degreesto about 30 degrees relative to the longitudinal axis “y”. This offsetarrangement will position catheter connector segment 2200 and/or cover2300 at an oblique arrangement with respect to the longitudinal axis “y”of tunneling stylet 2100, which may, e.g., facilitate initial insertionwithin the tunnel openings (e.g., the tunnel base opening or venotomyopening) in the tissue. For example, oblique leading end 2112 permitsthe clinician to introduce cover 2300 within the tunnel base opening atan angle thereby further displacing the clinician's hand from the chestarea of the subject. This offset arrangement of oblique leading end 2112and coupled with offset segment 2106 of handle 2104 addresses ergonomicconcerns and eases manipulation of tunneling stylet 2102 through thesubcutaneous tissue.

Cover 2300 may be initially releasably coupled to connector apparatus2200 to assist in advancing tunneling stylet 2100 through tissue priorto connection to catheter 200 in a similar manner as discussed inconnection with the embodiment of FIG. 1. Cover 2300 defines a generallyparabolic or bullet-shaped nose 2302 which, by its geometry, isatraumatic to tissue and facilitates the dissecting of tissue duringadvancement to form the subcutaneous tunnel. Cover 2300 also includescylindrical section 2304 depending from nose 2302 and collar 2306 at theend of the cylindrical section 2304. Collar 2306 defines a cross-sectionor diameter greater than the cross-section or diameter of cylindricalsection 2304 for positioning onto connector segment 2200. Cover 2300 mayinclude a plurality of axially extending ribs 2308 which may beperipherally or radially spaced about the exterior surface of cover2300, and extend from cylindrical section 2304 to collar 2306. Ribs 2308enhance gripping with fingers and facilitate rotational removal of cover2300. Recesses defined between the ribs 2308 may receive tissue portionsdisplaced during the tunneling procedure to facilitate advancementduring formation of the tunnel. In an alternate embodiment, cover 2300may include axial projections or ribs in lieu of, or in addition to,recesses 2308. The axial ribs may taper to increase the effective outerdimension of cylindrical section 2304 to correspond to the outerdimension of collar 2306. This arrangement may facilitate dissection oftissue to provide a more gradual transition from cylindrical section2304 to collar 2306. Cover 2300 may be fabricated from a biocompatiblepolymeric material or from a suitable elastomeric material capable ofslight deformation when mounted to connector segment 2200.

Although the illustrative embodiments of the present disclosure havebeen described herein with reference to the accompanying drawings, it isto be understood that the disclosure is not limited to those preciseembodiments, and that various other changes and modifications may beeffected therein by one skilled in the art without departing from thescope or spirit of the disclosure.

1-15. (canceled)
 16. An instrument for facilitating insertion of acatheter through a subcutaneous tunnel, which comprises: a tunnelingstylet having first and second segments, the first segment defining alongitudinal axis along at least a portion of a length thereof, thesecond segment being dimensioned for passage through tissue; abifurcated segment releasably connectable to the first segment, thebifurcated segment including first and second elements adapted forreception within respective lumens of the catheter; and a dilationmember releasably connectable to the first segment in the absence of thebifurcated segment, the dilation member dimensioned to generallyincrease an internal dimension of the subcutaneous tunnel.
 17. Theinstrument according to claim 16, wherein the first and second elementsof the bifurcated segment define first and second longitudinal lengths,the first longitudinal length being greater than the second longitudinallength.
 18. The instrument according to claim 16, wherein the first andsecond elements of the bifurcated segment each include a locking ribprotruding outwardly with respect to the longitudinal axis from an outersurface of the corresponding first and second elements, each locking ribbeing dimensioned to facilitate gripping engagement with an internalsurface of respective lumens of the catheter.
 19. The instrumentaccording to claim 16, wherein the first segment of the tunneling styletand the bifurcated segments include cooperative threaded portions forestablishing a releasable connection therebetween.
 20. The instrumentaccording to claim 16, wherein the first segment of the tunneling styletand the dilation member include cooperative threaded portions forestablishing a releasable connection therebetween. 21-22. (canceled) 23.The instrument according to claim 20, wherein the dilation memberincludes a trailing segment, an intermediate segment and a leadingsegment, and the dilation member defines an internal thread on an innersurface thereof to engage with an external thread on the first segmentof the tunneling stylet.
 24. The instrument according to claim 23,wherein the trailing segment of the dilation member includes a firsttapered segment and a first cylindrical segment, and the intermediatesegment includes a second tapered segment, a second cylindrical segmentand a third segment, the leading segment having a cylindricalconfiguration.
 25. The instrument according to claim 16, wherein thefirst segment of the tunneling stylet and the bifurcated segment includecooperative threaded portions for establishing a releasable connectiontherebetween.
 26. The instrument according to claim 16, wherein thesecond segment of the tunneling device extends from the first segment ofthe tunneling device and is obliquely arranged with respect to thelongitudinal axis.
 27. The instrument according to claim 26, wherein thesecond segment of the tunneling device defines a tapered configurationextending in a direction away from the longitudinal axis.
 28. Theinstrument according to claim 16, wherein the bifurcated segment has acollar from which the first and second elements of the bifurcatedsegment extend, the collar configured for flush engagement against anend face of the catheter.
 29. The instrument according to claim 16,wherein the first and second elements of the bifurcated segment areparallel to the longitudinal axis when the bifurcated segment isconnected to the first segment of the tunneling stylet.
 30. A systemcomprising: a catheter defining first and second lumens; a tunnelingstylet having first and second segments, the first segment defining alongitudinal axis along at least a portion of a length of the firstsegment, the second segment being dimensioned for passage throughtissue; a bifurcated segment releasably connectable to the firstsegment, the bifurcated segment including first and second elementspositionable within respective lumens of the catheter; and a dilationmember releasably connectable to the first segment in the absence of thebifurcated segment.
 31. The system of claim 30, wherein the dilationmember includes a trailing segment, an intermediate segment and aleading segment, and the dilation member defines an internal thread onan inner surface, an external surface of the first segment of thetunneling stylet defines an external thread engageable with the internalthread to releasably secure the dilation member to the tunneling stylet.32. The system of claim 31, wherein the trailing segment of the dilationmember includes a first tapered segment and a first cylindrical segment,and the intermediate segment includes a second tapered segment, a secondcylindrical segment and a third segment, the leading segment having acylindrical configuration.
 33. The system of claim 30, wherein thecatheter includes a cuff circumscribing the catheter and the dilationmember is sized to create a shelf in the wearer's tissue foraccommodating the cuff.